The Ischemia Modified Albumin In Diagnosing Ischemic New Events

Ischemic Heart Disease Clinical Trial

— IMAgine  

Official title:

The Ischemia Modified Albumin In Diagnosing Ischemic New Events (IMAGINE Study).

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00355992
• Other study ID #: IMA-0106-001.04
• Status: Terminated
• Phase: N/A
• First received: June 27, 2006
• Last updated: May 11, 2009
• Start date: September 2006
• Est. completion date: December 2007

Study information

• Verified date: May 2009
• Source: Inverness Medical Innovations
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

The purpose of the study is to evaluate the utility of Ischemia Modified Albumin (IMA) for risk stratification in patients presenting with chest discomfort and possible ischemic heart disease, and to evaluate the diagnostic and prognostic implication for IMA for major adverse cardiac events.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1250
• Est. completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Patients with primary complaints of chest discomfort or patients with symptoms indicative of a moderate to high probability for unstable angina clinically indicated reason for evaluation for ACS in the Emergency Department meeting tyhe following inclusion criteria will be enrolled:

• Age >=21 years

• Presentation within two hours of relief of most recent episode of chest pain or presence of on-going symptoms suggestive of coronary ischemia, which should be at least 10 minutes in duration.

• Patients being evaluated for suspected ischemic signs and or symptoms (chest pain) at the time of presentation according to routine standard of care institutional chest pain protocol/pathway.

Exclusion Criteria:

• Administration of thrombolytic medication prior to first (presentation) blood draw

• Acute coronary syndrome (ACS) secondary to supply/demand inequity (i.e. known anemia, tachycardia, - defined as HR greater than 150 bpm, known sepsis, hypotension, defined as blood pressure < 90 mmHg).

• Established diagnosis of liver cirrhosis

• Other acute ischemic sources (ongoing severe claudication, mesenteric ischemia, acute TIA/CVA)

• Renal failure requiring dialysis

• Greater than 2 hours from relief of the most recent episode of chest pain or signs and symptoms suggestive of coronary ischemia.

• Chest pain following traumatic injury to the chest

• Evidence for sever systemic infection, manifesting as fever (temperature >100 degrees) and systolic blood pressure <100 mmHg

• Patients unwilling or unable to provide written consent, without available next of kin

• Cocaine-related chest pain

• Pregnancy

• Known diagnosis of active malignancy

• Acute Bowel Ischemia

• Severe peripheral vascular disease

• Acute brain ischemia

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Angina, Unstable
• Coronary Artery Disease
• Heart Disease, Ischemic
• Heart Diseases
• Ischemia
• Ischemia, Myocardial
• Ischemic Heart Disease
• Myocardial Ischemia
• Unstable Angina

Locations

Country	Name	City	State
Canada	Hamilton General Hospital	Hamilton	Ontario
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	Dartmouth Medical Center	Lebanon	New Hampshire
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Inverness Medical Innovations

Countries where clinical trial is conducted

United States,  Canada,